Pharmalittle: We’re reading about MDMA ‘no’ votes, a Gilead settlement, and more

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy. So grab that cup of stimulation and get started. Our flavor today is mocha hazelnut, for those tracking our habits. Now, though, the time has come to get busy. So please grab your own cup and dig in to the items of interest assembled below. We hope you have a wonderful day, and please do keep in touch. …

In a surprisingly strong rejection of the first psychedelic therapy to come before the U.S. Food and Drug Administration, a scientific advisory panel on Tuesday overwhelmingly voted against the use of MDMA for treating PTSD, putting its approval in doubt, STAT tells us. At the end of a nine-hour meeting marked by sometimes-emotional testimony, the advisory committee voted 9-2 that the data do not show MDMA is effective in treating PTSD. The decision came after members critiqued the methodology of clinical trials by Lykos Therapeutics, which is seeking FDA approval for MDMA, and therapist oversight, rather than the drug itself.

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Gilead Sciences agreed to pay $40 million to more than 2,600 AIDS patients who claimed the company boosted profits by marketing an HIV drug without disclosing harmful side effects while delaying development of a safer alternative treatment, STAT writes. The agreement caps a dispute that cast a harsh spotlight on a strategy that Gilead allegedly used to maximize revenues and extend the lifespan of a best-selling product, but at the expense of patients. For its part, the company did not admit wrongdoing and continued to maintain it has “never stopped working to improve the lives of people with HIV.”

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